Back to the Top
The following message was posted to: PharmPK
Dear All,
As per product monograph, the therapeutic dose of Atazanavir is 400
mg. To achieve the therapeutic dose two capsules of 200-mg will be
given.
Atazanavir demonstrates non-linear pharmacokinetics with greater than
dose-proportional increases in AUC and Cmax values over the dose
range of 200-800 mg once daily.
So kindly suggest what to be done for non-linear pharmacokinetic
drugs whose Therapeutic dose is more than one tablet/capsule.
Also if we do bioequivalence on 200 mg then whether we can give two
capsules to achieve required therapeutic dose of 400 mg?
Awaiting for your expert comments,
Regards,
Nilesh Mhetre
CRA
Back to the Top
The following message was posted to: PharmPK
Dear,
For nonlinear drug if reference suggests about linerity or stable Pk
data after multiple dosing then go for Multiple dose study
considering the therapeutic dose only.
Hiren Mehta.
Cadila
Back to the Top
Dear,
You can do a single dose study with 2 tab or cap.
You cannot apply for bio waiver for lower doses.
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)